DSCSA Was Built for Security. It’s now a Strategic Advantage to enforce Market Access (Pablo Medina)

Lower drug costs are a noble cause, but the legitimacy of the supply chain is non-negotiable.

As pressure mounts to reduce specialty medication spend, alternative sourcing models are expanding. Innovation in affordability is important, especially for patients, but it should not compromise product integrity.

A recent federal complaint highlights the tension. In that case, a U.S.-prescribed specialty medication was allegedly fulfilled with a foreign-sourced version. The packaging differed, identifiers were unfamiliar, and providers were left questioning whether the product was legitimate, properly handled, and appropriate to administer.

How does DSCSA plays a role here?

The Drug Supply Chain Security Act establishes a closed, authorized U.S. supply chain. It requires:

• Transactions only among Authorized Trading Partners

• Serialized product identifiers

• Transaction data and statements validating legitimacy

• Verification and suspect-product investigation processes

These guardrails are designed to ensure that medicines dispensed in the U.S. originate within regulated channels.

When sourcing models operate outside that framework, legitimacy becomes harder to verify — even if cost savings are the intent.

DSCSA is not just a compliance requirement. It is infrastructure for trust.

The future of access must balance affordability with integrity.

DSCSA is the framework that allows both to coexist.

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Pablo Medina

Principal

Ten Count Consulting

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We are honored to help clients across the supply chain understand, comply with, and leverage the value cases that are growing as the adoption of DSCSA reaches fullness. Reach out to as at info@tencountconsulting.com to discuss how your organization is ensuring compliance and taking advantage of the significant investments required.